Device and method for assessing blood glucose control

ABSTRACT

A blood glucose and lifestyle tracking apparatus is disclosed. The blood glucose and lifestyle tracking apparatus provides a method for recording both blood glucose values for fasting, postprandial, and preprandial time periods and lifestyle factors.

BACKGROUND AND SUMMARY OF THE INVENTION

The present invention relates generally to methods for assessing controlof a health characteristic and in particular to methods for assessingcontrol of blood glucose.

It is known that the ability of a patient to control their blood glucoseimpacts other characteristics of their health. It is known for patient'sto take blood glucose readings with a blood glucose meter and to monitortheir blood glucose levels. Several software programs are availablewhich communicate with the blood glucose meter and provide reports forthe patient and doctor to analyze their blood glucose levels. Manypatients test randomly and infrequently and therefore their bloodglucose values do not provide an accurate and complete (time series)picture of their glycemic control. Patients may bring to theirphysician's office a completed logbook with no visualization, a bloodglucose meter on which the physician may scroll through values with novisualization, or a blood glucose meter whose values are downloaded to asoftware application which generates reports.

Many caregivers continue to monitor the blood glucose of a patient byperiodically taking a blood sample and having an HbA1c test performedwhich provides an indication of the patient's average blood glucoselevel. Therapy decisions by the caregiver are then based in part on theresults of the HbA1c test. This is especially true in the case ofnon-insulin type 2 patients. Further, the patient may make lifestyledecisions based in part on the results of the HbA1c test.

A patient's average blood glucose level does not always provide anadequate snapshot of a patient's glycemic control. As explained herein,by conducting episodic monitoring for a short period of time moreinformed therapy and/or lifestyle decisions may be made. This not onlyprovides a better standard of care for the patient, but also reduces thelikelihood of future complications and expenses; thereby causing thepatient to hopefully have a better quality of life.

In a exemplary embodiment of the present disclosure, an apparatus fortracking blood glucose values and lifestyle factors is provided. Theapparatus including: a substrate having a front side including aplurality of regions for tracking blood glucose values and a second sideincluding a portion having a plurality of instructions for using theplurality of regions for tracking blood glucose values. The substratebeing foldable such that the portion having the plurality ofinstructions on the second side overlap a portion of the front side.

In another exemplary embodiment of the present disclosure, an apparatusfor tracking blood glucose values and lifestyle factors is provided. Theapparatus including: a substrate having a front side including aplurality of regions for tracking blood glucose values. The plurality ofregions including a first region for recording an actual blood glucosevalue and a second region for placing a graphical marker indicating aselection of a first range of a plurality of ranges of blood glucosevalues. The plurality of ranges including at least one range below atarget range, at least one target range, and at least one range above atarget range.

In a further exemplary embodiment of the present disclosure, a method ofassessing blood glucose levels is provided. The method including thesteps of: receiving a blood glucose form over a network, the bloodglucose form including a plurality of indicia related to a plurality ofblood glucose readings; storing a plurality of database records based onthe plurality of indicia related to the plurality of blood glucosereadings; and providing at least one report based on the plurality ofdatabase records, the at least one report graphically representing atleast a portion of the plurality of indicia related to the plurality ofblood glucose readings.

In yet a further exemplary embodiment of the present disclosure, amethod of assessing blood glucose levels is provided. The methodincluding the steps of: providing a patient with a prescription for teststrips for a blood glucose meter and a blood glucose form; receiving theblood glucose form from the patient, the blood glucose form including aplurality of indicia related to a plurality of blood glucose readings ofthe blood glucose meter; and receiving at least one report based on theplurality of indicia related to the plurality of blood glucose readings.

In still another exemplary embodiment of the present disclosure, asystem for tracking physiological information with a blood glucose meteris provided. The system including: a plurality of test strips for usewith the blood glucose meter; and a blood glucose and lifestyle factorstracking apparatus for recording a plurality of blood glucose valuesdetermined by the blood glucose meter and corresponding lifestylefactors.

In yet another exemplary embodiment of the present disclosure, a methodof assessing blood glucose levels is provided. The method including thesteps of providing a patient with a blood glucose and lifestyle factorstracking apparatus and receiving the blood glucose form from thepatient. The blood glucose and lifestyle factors tracking apparatusincluding a first region for recording blood glucose values for at leasta first fasting time period, a first preprandial time period, and afirst postprandial time period for multiple consecutive days. The bloodglucose and lifestyle factors tracking apparatus further including asecond region for graphically representing the blood glucose valuesrecorded in the first region. The second region being placed so that afirst graphical marker in the second region corresponding to a firstblood glucose value in the first region are aligned. The blood glucoseand lifestyle factors tracking apparatus further including a thirdregion for recording at least one lifestyle factor for each bloodglucose value, the third region being positioned above the first region.The received blood glucose form including a plurality of manuallyrecorded blood glucose values, a manually drawn graphical representationof the plurality of manually recorded blood glucose values; and aplurality of manually recorded indicia for the at least one lifestylefactor for each manually recorded blood glucose value.

Additional features and advantages of the present invention will becomeapparent to those skilled in the art upon consideration of the followingdetailed description of illustrative embodiments exemplifying the bestmode of carrying out the invention as presently perceived.

BRIEF DESCRIPTION OF THE DRAWINGS

The detailed description of the drawings particularly refers to theaccompanying figures in which:

FIG. 1 is a front view of a blood glucose and lifestyle factors trackingapparatus.

FIGS. 1A-1C are detail portions of FIG. 1.

FIG. 2 is a back view of the blood glucose and lifestyle factorstracking apparatus of FIG. 1.

FIGS. 2A-2C are detail portions of FIG. 2.

FIG. 3 is the front view of the blood glucose and lifestyle factorstracking apparatus of FIG. 1 with an instruction panel of the back sideof the blood glucose and lifestyle factors tracking apparatus folded tooverlap a portion of the front side of the blood glucose and lifestylefactors tracking apparatus.

FIGS. 4A and 4B illustrate the glycemic variability for a first patientand a second patient, respectively.

FIG. 5 illustrates a completed blood glucose and lifestyle factorstracking apparatus for a first case study.

FIG. 6 illustrates a completed blood glucose and lifestyle factorstracking apparatus for a first case study.

FIG. 7 illustrates a completed blood glucose and lifestyle factorstracking apparatus for a first case study.

FIG. 8 illustrates a completed blood glucose and lifestyle factorstracking apparatus for a first case study.

FIG. 9 illustrates the mean change of blood glucose before and after ameal for a population based on meal size.

FIG. 10 is a representation of a system for analyzing the results of acompleted blood glucose and lifestyle factors tracking apparatus.

FIG. 11 is a representation of a method for analyzing the results of acompleted blood glucose and lifestyle factors tracking apparatus.

FIG. 12 is a representation of a kit including a blood glucose andlifestyle factors tracking apparatus.

DETAILED DESCRIPTION OF THE DRAWINGS

The embodiments of the invention described herein are not intended to beexhaustive or to limit the invention to the precise forms disclosed.Rather, the embodiments selected for description have been chosen toenable one skilled in the art to practice the invention.

Referring to FIG. 1, a front view of a blood glucose and lifestylefactors tracking apparatus 100 is shown. In one embodiment, bloodglucose and lifestyle factors tracking apparatus 100 is provided on asubstrate, such as a piece of paper or other foldable material. Bloodglucose and lifestyle factors tracking apparatus 100 provides a methodfor patients to track their blood glucose values and for caregivers tomake a more informed decision in therapy decisions.

With blood glucose and lifestyle factors tracking apparatus 100 patientsare asked to test their blood glucose for a short time with a structuredpattern. The data is captured via the blood glucose and lifestylefactors tracking apparatus 100. Caregivers may use blood glucose andlifestyle factors tracking apparatus 100, alone, or in combination withHbA1c to evaluate if the current therapy is effective, and if not, todetermine the best way to change the current therapy. The blood glucoseand lifestyle factors tracking apparatus 100 assists a caregiver inseeing the whole blood glucose picture of a patient, such as a patientwith non-insulin treated type 2 diabetes. The blood glucose andlifestyle factors tracking apparatus 100 also may be used with patientshaving type 1 diabetes. Blood glucose and lifestyle factors trackingapparatus 100 assists a caregiver to observe a patient's overallglycemic control as well as fasting, preprandial and postprandialvalues.

In one embodiment, a patient should complete blood glucose and lifestylefactors tracking apparatus 100 at least three to four times a yearbefore a regularly scheduled visit with their physician. In oneembodiment, the blood glucose and lifestyle factors tracking apparatus100 may be used at any time to evaluate a patient's response to newmedication, changes in lifestyle, stress or illness. The blood glucoseand lifestyle factors tracking apparatus 100 may be used as a gateway tothe consistent monitoring of blood glucose values with a blood glucosetracking software application.

Referring to FIG. 1, blood glucose and lifestyle factors trackingapparatus 100 includes a first region 102 for providing patientidentification information 104, insulin dosage information 106, oralmedications 108, and physician identification information 110. A secondregion 120 is provided for the recording of blood glucose values andlifestyle factors. Blood glucose and lifestyle factors trackingapparatus 100 provides for the tracking of blood glucose values andlifestyle factors for three consecutive days 122, 124, and 126. Althoughblood glucose and lifestyle factors tracking apparatus 100 provides forthe tracking of blood glucose values and lifestyle factors for threedays 122, 124, and 126, it should be understood that from two to morethan three days may be tracked instead.

First day 122 includes seven time periods 128-140. In a similar mannersecond day 124 includes seven time periods 142-154 and third day 126includes seven time periods 156-168. Although each day 122-126 includesseven time periods, less or more time periods may be used. The timeperiods include fasting time periods, preprandial time periods, andpostprandial time periods. Exemplary time periods for each day are“Before breakfast” (time periods 128, 142, and 156), “2 hours afterbreakfast” (time periods 130, 144, and 158); “Before lunch” (timeperiods 132, 146, and 160); “2 hours after lunch” (time periods 134,148, and 162); “Before dinner” (time periods 136, 150, and 164); “2hours after dinner” (time periods 138, 152, and 166); and “Before bed”(time periods 140, 154, and 168).

Blood glucose and lifestyle factors tracking apparatus 100 furtherincludes a row 170 for indicating an actual time that the blood glucosetest is taken. Row 170 includes a plurality of boxes for recording anindication of the times.

Blood glucose and lifestyle factors tracking apparatus 100 includes arow 172 for indicating a lifestyle factor, namely an indication of thesize of the meal eaten. Row 172 includes a plurality of boxes forrecording an indication of the size of meal eaten. Three graduations areprovided for meal size: small, medium, and large. A medium size meal isan average meal eaten by the person. The estimation of the meal size issubjective, so it is not possible to give an exact definition of small,medium and large food intake or to make a comparison between patientsbased on absolute volumes of food. It has been found that most peopleare consistent in their personal estimates of meal size over time. Inaddition, the fact that the patient has to think about the meal sizemakes him or her in most cases aware of the effect of food on selfmonitoring of blood glucose (SMBG) and his/her personal eating habits.The patient's blood glucose should always be measured before a meal or ascheduled meal. If the patient skips the meal he/she may either test twohours later anyway, or skip the test. A patient should use the Accu-Chek360° View at times with a consistent, stable schedule, if possible.

Blood glucose and lifestyle factors tracking apparatus 100 includes arow 174 for indicating a lifestyle factor, namely an indication of anenergy level of the person. Row 174 includes a plurality of boxes forrecording an indication of the patient's energy level. Five graduationsof energy level are provided: 1, 2, 3, 4, and 5. An explanation of thegraduations is provided in region 176.

Blood glucose and lifestyle factors tracking apparatus 100 furtherincludes a row 178 for indicating the actual measured blood glucosevalue for each time period. Row 178 includes a plurality of boxes forrecording an indication of the blood glucose values. In one embodiment,the blood glucose values are measured with a blood glucose meter.Exemplary blood glucose meters include Accu-Chek Aviva and Accu-ChekAdvantage, both available from Roche Diagnostics located inIndianapolis, Ind. In one embodiment, row 174 is positioned above row178 so that the patient records their energy level prior to recordingtheir blood glucose value. In this manner, the magnitude of the bloodglucose value should not be focused on by the patient in choosing thecorresponding energy level.

The patient is also to graph the measured blood glucose values in region180. Region 180 includes a plurality of rows 182-198, each including atextual label indicating the range of blood glucose values correspondingto the respective row. Rows 182-192 correspond to various blood glucosevalues above the target ranges. Row 194 corresponds to the blood glucoserange corresponding to an after meal (postprandial) target bloodglucose. Row 196 corresponds to the blood glucose range corresponding toa before meal (preprandial) target blood glucose. Rows 196 and 198correspond to various blood glucose values below the target ranges.

In one embodiment, the entire rows 194 and 196 of blood glucose andlifestyle factors tracking apparatus 100 have a visual indicator toindicate that they correspond to target ranges. In one embodiment, thevisual indicator is a color differentiation from the remaining rows182-190, 196, and 198. In one example, rows 194 and 196 are yellow. Inone embodiment, one or more of the columns for each day 122-126 alsoinclude a visual indicator. In one example, columns 130, 144, and 158are a first shade of blue, columns 134, 148, and 162 are a shade ofpurple, columns 138, 152, and 166 are a second shade of blue, and theremaining columns are white except that they are yellow in the areasoverlapping rows 194 and 196. In a similar manner, columns 130, 134,138, 144, 148, 152, 158, 162, and 166 also have a yellowish tint in theareas overlapping rows 194 and 196. The color scheme of blood glucoseand lifestyle factors tracking apparatus 100 allows for: ease ofanalysis, pattern recognition for different times of the day, easyrecognition of normal values, and faxing and scanning into electronicmedical records. In one embodiment, the length A and width B of bloodglucose and lifestyle factors tracking apparatus 100 is selected tocorrespond to the size paper used for physical medical records in therespective countries.

Referring to FIG. 2, a back side of blood glucose and lifestyle factorstracking apparatus 100 includes an illustration of a completed frontside of blood glucose and lifestyle factors tracking apparatus 100 inregion 202. A detail view of a portion of region 202 is shown in FIG.2A. Further, blood glucose and lifestyle factors tracking apparatus 100includes a note to the user in region 204 on how to align a plurality ofinstructions 206 presented in region 208 with the front side of bloodglucose and lifestyle factors tracking apparatus 100. As shown in FIGS.1 and 2, blood glucose and lifestyle factors tracking apparatus 100 hasa length A and a width B. Region 208 including plurality of instructions206 has a length C. As shown in FIG. 3, by folding region 208 over aportion of the front side of blood glucose and lifestyle factorstracking apparatus 100 the plurality of instructions 206 in region 208overlaps a portion of the front side of blood glucose and lifestylefactors tracking apparatus 100.

Plurality of instructions 206 illustratively include seven instructions210-222. Instruction 210 instructs the user to fill in the dates for thedays on which the patient will track his/her blood glucose valuesindicated by arrow 211. Instruction 212 instructs the user to performthe blood glucose tests in the time periods indicated by arrow 213.Instruction 214 instructs the user to provide the time for the bloodglucose tests in row 170 as indicated by arrow 215. Instruction 216instructs the user to, based on his/her normal eating habits, describethe meal size in row 172 as indicated by arrow 217. Instruction 218instructs the user to provide an indication of his/her energy level inrow 174 as indicated by arrow 219. Instruction 220 instructs the user toprovide his/her blood glucose value in row 178 as indicated by arrow221. Instruction 222 instructs the user to place an “X” in the rowcorresponding to the measured blood glucose and to connect the “X's”together as indicated by arrow 223.

The completed blood glucose and lifestyle factors tracking apparatus 100is taken to the caregiver. Exemplary caregivers include a physician, apharmacist or a diabetes nurse. The caregiver and the patient discussthe results of the three-day profile conducted with blood glucose andlifestyle factors tracking apparatus 100 and then decide what actions totake based on the results. The caregiver uses the self-monitoring dataof the blood glucose and lifestyle factors tracking apparatus 100 andother information, such as HbA1c (if available), to decide if thecurrent therapy is effective, and if not, to determine a change in thetherapy. Caregivers often make decisions on treatment of patients withnon-insulin treated type 2 diabetes solely based on HbA1c which is avaluable factor for the assessment of long-term glycemic control. ButHbA1c does not tell the caregiver anything about short-term fluctuationsof blood glucose levels which could lead to macrovascular complications.

It is well known that cardiovascular disease is the leading cause ofdeath in patients with type 2 diabetes. Cardiovascular disease accountsfor about forty percent of all deaths in diabetic patients. Bloodglucose levels in all persons, including diabetes patients, are subjectto temporal variations, called glycemic variability.

The connection between risk for cardiovascular disease and glycemicvariability has been demonstrated in several studies. Wide glucosefluctuations, independent of mean glucose, are highly correlated withmacrovascular complications in patients with type 2 diabetes. Animportant surrogate marker for glycemic variability is a patient'spostprandial blood glucose levels. One study confirms the postprandialblood glucose levels as an independent risk factor for macrovascularcomplications: an increase of postprandial blood glucose levels of 1mmol/l (approximately 18 mg/dl) leads to a mean increase of mortality of8%. Recent research suggests that glucose fluctuations duringpostprandial periods and, more generally, during glucose swings, exhibita more specific triggering effect on oxidative stress than chronicsustained hyperglycemia. Thus, one of the mechanisms by which diabetescauses cardiovascular complications may be oxidative stress due toglucose variability.

Another investigation showed that atherosclerotic plaques may diminishif postprandial hyperglycemia is reduced. A further investigation showeda relative risk reduction for the development of cardiovascular events(nearly 50%) and in the development of new cases of hypertension (34%)in patients whose postprandial hyperglycemic values could be reduced. Inaddition, patients by understanding the connection to heart disease aremore likely to monitor their blood glucose values than the traditionalcomplications with diabetes, namely amputation and blindness.

Referring to FIGS. 4A and 4B, the glycemic variability of a firstpatient, graph 250, and a second patient, graph 252, are shown. Thesecond patient has a much higher glycemic variability than the firstpatent and is at a higher risk for macrovascular complications. However,a caregiver relying on HbA1c alone would not detect this differencebetween the first patient and the second patient. In fact, both thefirst patient and the second patient have generally the same HbA1c of7.0% which equates to a mean blood glucose level of 170 mg/dl. (9.5mmol/l). The treatment strategy for the first patient and the secondpatient may be different based on glycemic variability. For patient Athe focus may be on reducing the fasting glucose first. For patient Bthe focus may also be on reducing the postprandial glucose.

The blood glucose and lifestyle factors tracking apparatus 100 isdesigned to monitor patients' glycemic variability in a simple, visualway to help achieve the goal of controlling glycemic variability. Theblood glucose and lifestyle factors tracking apparatus 100 assists thecaregiver to visualize overall glycemic control as well as fasting,preprandial and postprandial values. Four case studies are presented inFIGS. 5-8 to illustrate the use of blood glucose and lifestyle factorstracking apparatus 100.

Referring to FIG. 5, a completed blood glucose and lifestyle factorstracking apparatus 100 for a first patient named Beth is shown. Beth isa 72 year old Caucasian who has type 2 diabetes for 21 years. She iscurrently taking metformin 500 mg twice a day and Amaryl 4 mg withbreakfast. She has raisin toast with coffee for breakfast. Her HbA1c1 is6.8%.

A caregiver may consider the following questions when looking at theresults depicted by blood glucose and lifestyle factors trackingapparatus 100. First, are most of the values at, above or below goal?Second, is there evidence of hypoglycemia? Third, are the fastingglucose values (i.e. before breakfast) consistently at, above or belowgoal? Fourth, are the preprandial glucose values (i.e. before meal)consistently at, above or below goal? Fifth, are the postprandialglucose values (i.e. after meal) consistently at, above or below goal? Acaregiver may also consider the glycemic variability of Beth byconsidering from blood glucose and lifestyle factors tracking apparatus100: Are postprandial values consistently >100 mg/dl (5.5 mmol/l) higherthan preprandial values?

Referring to Table I, the answers to these inquiries are provided froman analysis of Beth's blood glucose and lifestyle factors trackingapparatus 100 along with some potential changes to therapy and/orlifestyle.

TABLE I Glycemic At, above or control factors below goal Possibleactions HbA_(1c) at or below Slightly above Education, lifestyle changestarget of ≦6.5%? target and possible medication adjustment or change Aremost of the values at, Mostly above Education, lifestyle changes aboveor below goal? goal and possible medication adjustment or change Isthere evidence of No hypoglycemia? Are the fasting glucose Above goalEducation, lifestyle changes values consistently at, and possiblemedication above or below goal? adjustment or change Are the preprandialglucose Mostly above Education, lifestyle changes values consistentlyat, above goal and possible medication or below goal? adjustment orchange Are the postprandial glucose Frequently Learn how food affectsvalues consistently at, above above goal SMBG values, education, orbelow goal? lifestyle changes and evaluation Glycemic variability: AreNo of medication postprandial values (Indication that consistentlyglycemic >100 mg/dl (5.5 mmol/l) variability is higher than preprandialprobably ok) values?

Referring to FIG. 6, a completed blood glucose and lifestyle factorstracking apparatus 100 for a second patient named George is shown.George is a 76 year old male African American who has had type 2diabetes for 2 years. He is currently taken pioglitazone 45 mg withbreakfast and metforim 500 mg four times a day. His HbA1c today is 12.7%

Referring to Table II, the answers to the above inquiries are providedfrom an analysis of George's blood glucose and lifestyle factorstracking apparatus 100 along with some potential changes to therapyand/or lifestyle.

TABLE II At, above or Glycemic control factors below goal Possibleactions HbA_(1c) at or below target No, far Education, lifestyle changesof ≦6.5%? above target and possible medication adjustment or change;encourage patient to stick with dietary changes he is already making Aremost of the values at, Consistently Education, lifestyle changes aboveor below goal? above goal and possible medication adjustment or changeIs there evidence of No hypoglycemia? Are the fasting glucose valuesConsistently Education, lifestyle changes consistently at, above orabove goal and possible medication below goal? adjustment or change;consider adding basal insulin Are the preprandial glucose ConsistentlyConsider treating fasting values consistently at, above above goalhyperglycemia first; re- or below goal? check pre- and post- prandialvalues after fasting Are the postprandial glucose Consistently Learn howfood affects values consistently at, above above goal SMBG values;consider or below goal? consulting with dietician; consider addingincretin agent or preprandial insulin Glycemic variability: Are Reassessafter fasting postprandial values hyperglycemia is addressedconsistently >100 mg/dl (5.5 mmol/l) higher than preprandial values?

Referring to FIG. 7, a completed blood glucose and lifestyle factorstracking apparatus 100 for a third patient named Maria is shown. Mariahas significant hypoglycemic events. Maria is a 86 year old femaleCaucasian who has had type 2 diabetes for 5 years. She is currentlytaking glipizide 5 mg with breakfast and before bed. She feels weak andshaky before meals and feels a lot better after she has eaten. Her HbA1ctoday is 5.9%.

Referring to Table III, the answers to the above inquiries are providedfrom an analysis of Maria's blood glucose and lifestyle factors trackingapparatus 100 along with some potential changes to therapy and/orlifestyle.

TABLE III Glycemic At, above or control factors below goal Possibleactions HbA_(1c) at or below target Within target Within normal rangebut of ≦6.5% ¹? patient complains of symptoms that may be consistentwith hypoglycemia Are most of the values at, Mostly below Considerreducing dose of above or below goal? goal current medication andfrequency of administration Is there evidence of Yes, Consider reducingdose of hypoglycemia? especially current medication and before mealsfrequency of administration Are the fasting glucose values ConsistentlyConsider reducing dose of consistently at, above or below goal currentmedication and below goal? frequency of administration Are thepreprandial glucose Frequently Resolve hypoglycemia and valuesconsistently at, above below goal re-evaluate. or below goal? Are thepostprandial glucose Mostly at goal Resolve hypoglycemia and valuesconsistently at, above re-evaluate; learn or below goal? how foodaffects SMBG values Glycemic variability: Are Re-assess afterpostprandial values consistently hypoglycemia is >100 mg/dl (5.5 mmol/l)addressed. higher than preprandial values?

Referring to FIG. 8, a completed blood glucose and lifestyle factorstracking apparatus 100 for a fourth patient named Giovanni is shown.Giovanni consistently shows postprandial hyperglycemia. GiovanniBellinin is a 69 year old male Caucasian who has had type 2 diabetes for2 years. He is currently taking glimepiride 1 mg with breakfast. He hasrecently discovered that he feels better if he eats smaller, morefrequent meals. His HbA1c is 7.5%

Referring to Table IV, the answers to the above inquiries are providedfrom an analysis of Giovanni's blood glucose and lifestyle factorstracking apparatus 100 along with some potential changes to therapyand/or lifestyle.

TABLE IV Glycemic At, above or control factors below goal Possibleactions HbA_(1c) at or below Above target Examine SMBG data to target of≦6.5% ¹? determine best options for adjusting therapy Are most of thevalues at, Mostly above Education, lifestyle changes above or belowgoal? goal Is there evidence of No hypoglycemia? Are the fasting glucosevalues Most (2/3) consistently at, above or below fasting values goal?are at goal Are the preprandial glucose Some are at values consistentlyat, above or goal but some below goal? are above Are the postprandialglucose Consistently Learn how food affects values consistently at,above or above goal SMBG values, consider below goal? medicationadjustment or change; consider incretin agents for post-prandial controlGlycemic variability: Are Possibly Re-assess after treating postprandialvalues consistently higher than postprandial hyperglycemia >100 mg/dl(5.5 mmol/l) desirable with higher large post- than preprandial values?prandial excursions.

The use of blood glucose and lifestyle factors tracking apparatus 100not only provides a look at the blood glucose values, but also tiesthose values to lifestyle factors, namely meal size and energy level.Referring to FIG. 9, the mean change in blood glucose value frompreprandial to two-hours postprandial for thirty subjects with diabeteshaving a mean age of sixty-six years and a mean duration of diabetes of9.6 years are provided. The group had a mean HbA1c of 8.0%. Based onHbAc1 alone, this group of subjects would be considered by many primarycare physicians to have decent control and not warrant a therapy change.However, as an analysis of data derived from the completed blood glucoseand lifestyle factors tracking apparatus 100 for the patients, thisgroup of patients have significant postprandial excursions in themorning due partly to increased insulin resistance and partly to mealsize. The glycemic variability is considerably less at lunch and dinnerbut still significant for those eating large meals.

The effectiveness of episodic monitoring of blood glucose on improvingpatient care was studied in a study presented as a poster at theEuropean Association for the Study of Diabetes in September 2007 titled“Primary Care Physicians Identify and Act on Glycemic AbnormalitiesFound in Episodic, Intensive Blood Glucose Monitoring Data fromNon-Insulin Treated Type 2 Diabetics.” As stated herein, primary carephysicians often make therapy adjustments for non-insulin treated type 2diabetics on the basis of HbA1c alone without consideringself-monitoring blood glucose (SMBG) data. The purpose of this study wasto determine if primary care physicians could accurately identifyglycemic abnormalities in episodic (short term), intensive SMBG datafrom non-insulin treated type 2 diabetics and if their therapeuticdecisions would be changed by evaluation of SMBG data.

In the study twenty-three case studies demonstrating a range of glycemicstates were prepared from data obtained from subjects with type 2diabetics who participated in a prior clinical trial on episodic,intensive SMBG. Case studies included patients' history, currentmedications, current HbA1c values, and 3-7 days of SMBG data. Fivediabetes care experts evaluated the case studies, identified glycemicabnormalities, and determined if and how the patients' therapy should bechanged. Subsequently, board certified family practitioners andinternists evaluated the case studies first without SMBG data and thenwith SMBG data. Their interpretations of the SMBG data were compared tothe interpretations of the experts. The primary care physicians'therapeutic recommendations for case studies without SMBG data werecompared to those the primary care physicians made for case studies withSMBG data to determine if the availability of SMBG data in addition toHbA1c values changed the primary care physicians' therapeuticrecommendations. At the end of the study, a survey questionnaireevaluating the value of episodic SMBG data in addition to HbA1c resultswas administered.

In reviewing the case studies with SMBG data, 78% of the primary carephysicians correctly identified normoglycemia, hypoglycemia,hyperglycemia, elevated fasting values and elevated postprandial values.When the primary care physicians assessed case studies with SMBG data,77% of them changed the therapeutic decisions they had made previouslywhen evaluating the case studies without SMBG data. When hypoglycemiawas identified, primary care physicians decided to change the time thecurrent medication was given, reduce the dose of the current medication,discontinue the medication altogether, or change to a new medication.When frequently elevated fasting levels or elevated postprandial SMBGlevels were apparent, primary care physicians elected to change the timethe current medication was given, increase the dose of the currentmedication, switch to a new medication, or add a new medication to thecurrent treatment regime.

Primary care physicians were asked to assess the added value of SMBGdata when presented with HbA1c data. Approximately 86% of the primarycare physicians found the SMBG information to be of equal or greatervalue than the HbA1c while less than 14% found it to be of lesser or novalue. This study shows that primary care physicians may correctlyidentify glycemic abnormalities in episodic, intensive SMBG data.Indeed, PCP's assessment of the SMBG data prompted most of them tochange the therapeutic choices made initially when the case studies didnot include the SMBG data. In addition, the vast majority ofparticipating PCPs found the SMBG data to be valuable when evaluatingthe case studies.

The effectiveness of blood glucose and lifestyle factors trackingapparatus 100 on improving patient care was studied in a study presentedat the American Diabetes Association in 2007 titled “Development of aNovel bG Analysis System for Episodic bG Monitoring in Persons with Type2 Diabetes.”

In the study, thirty subjects with type 2 diabetes used the bloodglucose and lifestyle factors tracking apparatus 100 to determine if thesubjects could use and learn from the system. The subjects were trainedto use a blood glucose meter and the blood glucose and lifestyle factorstracking apparatus 100. On completion of the study, the blood glucosemeters were downloaded, the blood glucose and lifestyle factors trackingapparatus 100 were collected, and the subjects completed aquestionnaire. Table V represents the demographics of the subjects.

TABLE V Duration Self- of Self-reported reported Age Gender Diabetes A1cbG bG (years) (M/F) (years) (%) tests/day tests/week 66 +/− 9.6 15/159.6 +/− 6.3 8.0 +/− 1.8 +/− 0.9 6.1 +/− 1.5 2.1

After training and familiarization with blood glucose and lifestylefactors tracking apparatus 100, written blood glucose values in row 178on the completed blood glucose and lifestyle factors tracking apparatus100 matched meter downloads greater than 90% of the time. The subjectsrated the following features of blood glucose and lifestyle factorstracking apparatus 100 identified in Table VI on a scale of 1 to 7 with1 being the most positive response:

TABLE VI Presence # of of Presence of Easy to # of Test Tests per bG TooHigh/Low Complete Days Day Targets Ranges 1.6 +/− 0.9 1.6 +/− 0.9 3.6+/− 2.0 1.4 +/− 0.8 1.5 +/− 0.9

Many of the subjects reported being genuinely surprised by their bloodglucose readings and 68% of subjects made correlations between meal sizeand postprandial blood glucose values. Many of the subjects wanted totake their completed blood glucose and lifestyle factors trackingapparatus 100 to their physicians. More than 90% of the subjects saidthat despite the test frequency, they would be willing to use the bloodglucose and lifestyle factors tracking apparatus 100 again every 3months if asked to by their physicians. These findings indicate thatpersons with type 2 diabetes are willing to perform episodic bloodglucose monitoring if their physicians ask them to, can learn fromcompleting the blood glucose and lifestyle factors tracking apparatus100, and might be more motivated to improve their diabetes self-care asa result.

Blood glucose and lifestyle factors tracking apparatus 100 may beimplemented in a variety of implementation scenarios. A first scenariois in conjunction with a physician's office. The physician's officecontacts the patient two weeks prior to the next scheduled office visitto remind the patient about the next appointment and to inform aboutimportant testing materials the physician wants the patient to completebeforehand and discuss at the next appointment. The physician's officemails the blood glucose and lifestyle factors tracking apparatus 100 tothe patient together with a test strip prescription for test strips fora blood glucose meter. In one embodiment, the blood glucose andlifestyle factors tracking apparatus 100 is packaged with the teststrips for the blood glucose meter and the physician simply provides atest strip prescription. The patient completes the blood glucose andlifestyle factors tracking apparatus 100 prior to the office visit andbrings the completed blood glucose and lifestyle factors trackingapparatus 100 to the office visit. The physician and the patient discussthe completed blood glucose and lifestyle factors tracking apparatus 100together and decide on potential therapy changes.

A second scenario is for emerging markets. In an emerging market, bloodglucose meters are generally scarce and self-monitoring of blood glucoseis rarely performed. Further, HbA1c testing is often not performed. Apool of blood glucose meters are provided to a care facility. Anexemplary care facility is a regional hospital. A patient borrows ameter from the pool of meters provided to the regional hospital. Thepatient also receives a test strip prescription and the blood glucoseand lifestyle factors tracking apparatus 100. In one embodiment, bloodglucose and lifestyle factors tracking apparatus 100 is packaged withthe test strips for the blood glucose meter and the physician simplyprovides a test strip prescription along with the meter from the pool ofmeters. The patient tests his/her blood glucose for three days andrecords the results along with the lifestyle factors with blood glucoseand lifestyle factors tracking apparatus 100. The following week thepatient returns the meter and the completed blood glucose and lifestylefactors tracking apparatus 100 to his/her physician in the regionalhospital during an in-office consultation. The physician discusses theresults with the patient, evaluates the current therapy, and makessuggestions for changes in therapy or lifestyle, if applicable. Themeter is returned to the pool of meters after cleaning to preventcross-contamination of blood.

A third scenario is for a care facility setting. A diabetes center inthe care facility calls the patient prior to the next scheduled officevisit to remind the patient about the next appointment and to lethim/her know, that he/she will be receiving important testing materialsto be completed and discussed at the appointment. In one embodiment, thepatient is contacted about two weeks prior to the next scheduled officevisit. The care facility mails or otherwise provides the blood glucoseand lifestyle factors tracking apparatus 100 to the patient togetherwith a test strip prescription. In one embodiment, blood glucose andlifestyle factors tracking apparatus 100 is packaged with the teststrips for the blood glucose meter and the care facility simply providesa test strip prescription to the patient.

Referring to FIG. 12, an exemplary kit 400 including a plurality of teststrips 402 and blood glucose and lifestyle factors tracking apparatus100 is represented. Both the plurality of test strips 402 and bloodglucose and lifestyle factors tracking apparatus 100 are provided withinpackaging 404. In one embodiment, education information 406 is alsoprovided in kit 400. Exemplary educational information 406 includes mealplanning information 408, hypoglycemia information 410, hyperglycemiainformation 412, and consultation forms 414.

Returning to the third scenario, the patient tests for three days withthe blood glucose and lifestyle factors tracking apparatus 100 andreturns the completed blood glucose and lifestyle factors trackingapparatus 100 at his/her next appointment. The physician and the patientdiscuss results, evaluate the current therapy, and discuss changes tothe therapy and/or lifestyle.

A fourth scenario is for pharmacists. The pharmacist gives the patientthe blood glucose and lifestyle factors tracking apparatus 100 whenbuying a new meter and/or test strips. In one embodiment, blood glucoseand lifestyle factors tracking apparatus 100 is packaged with the teststrips for the blood glucose meter or with the meter. In one embodiment,blood glucose and lifestyle factors tracking apparatus 100 is providedas part of a kit 400 including one or more blood glucose and lifestylefactors tracking apparatus 100, educational sheets on hypoglycemia,hyperglycemia, and meal planning, and consultation forms. The patient isasked to complete the blood glucose and lifestyle factors trackingapparatus 100 and return the completed blood glucose and lifestylefactors tracking apparatus 100 to the pharmacist. In one embodiment, thepharmacist evaluates the effectiveness of the current therapy andcounsels the patient on how he responds to food and medication andprovides recommendations. The pharmacist may offer to share theevaluation with the patient's primary care physician. In one embodiment,pharmacists may receive reimbursement for counseling services.

This scenario has many benefits for the patient, the pharmacist, and thephysician. Regarding benefits for the patient, the pharmacist trains thepatient in the proper use of the meter. Further, the patient learns howdiet affect their blood glucose values. Additionally, the patient getsused to using the blood glucose and lifestyle factors tracking apparatus100 on a regular basis. Finally, the physician is likely to intensifytherapy more quickly leading potentially to better outcomes for thepatient. Regarding benefits for the pharmacist, the pharmacist providesgreater value to the patient through training and analysis of therapy.The pharmacist has improved job satisfaction because they are more fullyutilizing their training and education. Additionally, the customerrelations with both patients and physicians to the pharmacist are likelystrengthened. Regarding benefits for the physician, the physician gets asecond opinion on the effectiveness of the patient's therapy and hasappointments with patients to discuss the results. Further, thephysician may use the information provided by the blood glucose andlifestyle factors tracking apparatus 100 to intensify therapy which willlikely achieve better outcomes for the patient and may earn more frompayers.

In one embodiment, a completed blood glucose and lifestyle factorstracking apparatus 100 is input to a computing device 300 to provideadditional analysis of the data indicated on the completed blood glucoseand lifestyle factors tracking apparatus 100 and/or to compare the dataon the completed blood glucose and lifestyle factors tracking apparatus100 to historical data for the patient. In one embodiment, thehistorical data is derived for prior instances of the completed bloodglucose and lifestyle factors tracking apparatus 100.

Referring to FIG. 10, a computing device 300 is shown. Computing device300 may be a general purpose computer or a portable computing device.Although computing device 300 is illustrated as a single computingdevice, it should be understood that multiple computing devices may beused together, such as over a network or other methods of transferringdata. Exemplary computing devices include desktop computers, laptopcomputers, personal data assistants (“PDA”), such as BLACKBERRY branddevices, cellular devices, tablet computers, infusion pumps, bloodglucose meters, or an integrated device including a glucose measurementengine and a PDA or cell phone.

Computing device 300 has access to a memory 302. Memory 302 is acomputer readable medium and may be a single storage device or multiplestorage devices, located either locally with computing device 300 oraccessible across a network. Computer-readable media may be anyavailable media that can be accessed by the computing device 300 andincludes both volatile and non-volatile media. Further, computerreadable-media may be one or both of removable and non-removable media.By way of example, and not limitation, computer-readable media maycomprise computer storage media. Exemplary computer storage mediaincludes, but is not limited to, RAM, ROM, EEPROM, flash memory or othermemory technology, CD-ROM, Digital Versatile Disk (DVD) or other opticaldisk storage, magnetic cassettes, magnetic tape, magnetic disk storageor other magnetic storage devices, or any other medium which can be usedto store the desired information and which can be accessed by thecomputing device 300.

Memory 302 includes one or more patient databases 304 and healthcaremanagement software system 306. Patient databases 304 includephysiological information 308 related to one or more patients. Exemplaryphysiological information includes blood glucose values, HbA1c values,Albumin values, Albumin excretion values, body mass index values, bloodpressure values, carbohydrate values, cholesterol values (total, HDL,LDL, ratio) creatinine values, fructosamine values, HbA1 values, heightvalues, insulin dose values, insulin rate values, total daily insulinvalues, ketone values, microalbumin values, proteinuria values, heartrate values, temperature values, triglyceride values, and weight values.Physiological information 308 may be provided directly by the patient,provided by a caregiver, and/or provided by one or more sensors.Exemplary sensors are provided in insulin pumps and glucose meters. Thephysiological information 308 is related to time information 310 whichcorresponds to the time the measurement was taken or represents a periodof time within which a measurement was taken. Patient databases 304further include lifestyle factors information 312. Lifestyle factorsinformation 312 is related to time information 310 and/or physiologicalinformation 308.

Computing device 300 has access to one or more input devices 314 and oneor more output device 316. Exemplary input device 314 include a copier318, a scanner 320, and a fax machine 322. The input device 314 is ableto receive a completed blood glucose and lifestyle factors trackingapparatus 100 and provide an electronic representation of the datathereon. Exemplary output devices 112 include a fax machine 322, adisplay 324, a printer 326, and a file 328. File 328 may have variousformats. In one embodiment, file 328 is a portable document format (PDF)file. In one embodiment, file 328 is formatted for display by anInternet browser, such as Internet Explorer available from Microsoft ofRedmond, Wash., and may include one or more of HyperText Markup Language(“HTML”), or other formatting instructions. In one embodiment, file 328is a file stored in memory 302 for transmission to another computingdevice and eventual presentation by another output device or to at leastinfluence information provided by the another output device.

In one embodiment, the completed blood glucose and lifestyle factorstracking apparatus 100 is provided to an exemplary input device 314. Theinput device 314 provides an electronic representation 330 of the dataprovided on the completed blood glucose and lifestyle factors trackingapparatus 100. The electronic representation 330 is provided tocomputing device 300. Computing device 300 inputs the electronicrepresentation 330 into patient database 304 through healthcaremanagement software system 306. Computing device 300 then generates anelectronic report 332 with healthcare management software system 306.The electronic report 332 is provided to output device 316. With outputdevice 316, a user may produce a hard copy report 334.

Healthcare management software system 306 includes instructions whichwhen executed by computing device 300 present physiological information308 or information based on physiological information 308 to an outputdevice 316. Exemplary information presented by healthcare managementsoftware system 306 to output device 316 include diaries of bloodglucose values and reports showing a plurality of blood glucose valuesand the times or times blocks to which the blood glucose valuescorrespond. Exemplary reports include standard day reports wherein theblood glucose values are grouped according to the time of day taken,standard week reports wherein the blood glucose values are groupedaccording to the day of the week taken, trend graphs to illustratetemporal trends in blood glucose values, and other suitable reportsand/or graphs.

Referring to FIG. 11, an exemplary representation of the processing of acompleted blood glucose and lifestyle factors tracking apparatus 100 isshown. A completed blood glucose and lifestyle factors trackingapparatus 100 is taken by the patient to a caregiver site. An exemplarycaregiver site is the patient's primary physician's office. Thecompleted blood glucose and lifestyle factors tracking apparatus 100 isconverted into an electronic representation 330 of the completed bloodglucose and lifestyle factors tracking apparatus 100. In one embodiment,the electronic form of the completed blood glucose and lifestyle factorstracking apparatus 100 does not retain details regarding the appearanceof the blood glucose and lifestyle factors tracking apparatus 100, butsimply rather just a representation of the data provided on thecompleted blood glucose and lifestyle factors tracking apparatus 100.

The electronic representation 330 is transferred over a network 350 to aremote site. Exemplary networks include the internet, a phone network, acellular network, a cable network, a local area network, a wide arenetwork, and other suitable networks. At the remote site data conversionsoftware 352 extracts the data provided in the completed blood glucoseand lifestyle factors tracking apparatus 100 from electronicrepresentation 330. In one embodiment, wherein a scanned view ofcompleted blood glucose and lifestyle factors tracking apparatus 100 isprovided to data conversion software 352, data conversion software 352includes optical character recognition software to convert handwritteninformation into digital information.

The data derived from electronic representation 330 is stored in patientdatabase 304. Healthcare management software system 306 generates one ormore reports 332 including information derived from electronicrepresentation 330. In one embodiment, electronic report 332 furtherincludes historical data or other physiological information 308 providedin patient database 304. Exemplary reports may provide a mean glucosevalue, a percentage of blood glucose values in and out of range, trendanalysis, and other suitable pieces of information.

Reports 332 are transferred back through network 350 to an output device316 at the caregiver's site. At the caregiver's site a hard copy 354 ofthe report may be generated for the patient, for the caregiver, and/orfor the patient file.

In one embodiment, computing device 300 includes software which based onthe recorded blood glucose values, the time period of the blood glucosevalues (preprandial, postprandial, fasting), the recorded responses tothe lifestyle factors, and/or additional information (medicationinformation and insulin type and dosage) provides to the doctor at leastone of an analysis of the patient's current therapy and one or moresuggested changes to the current therapy, if any. For instance, based onthe information related to George the software would recognize that thepostprandial glucose values are consistently above goal and suggest thatGeorge consult with a dietitian to learn how food affects SMBG values,suggest adding an incretin agent, and/or suggest adding preprandialinsulin.

Although the invention has been described in detail with reference tocertain preferred embodiments, variations and modifications exist withinthe spirit and scope of the invention as described and defined in thefollowing claims.

1. An apparatus for tracking blood glucose values and lifestyle factors,the apparatus including: a substrate having a front side including aplurality of regions for tracking blood glucose values and a second sideincluding a portion having a plurality of instructions for using theplurality of regions for tracking blood glucose values, the substratebeing foldable such that the portion having the plurality ofinstructions on the second side overlap a portion of the front side. 2.The apparatus of claim 1, wherein the plurality of instructions overlapa portion of the plurality of regions for tracking blood glucose values.3. The apparatus of claim 2, wherein the front side further includes aplurality of regions for tracking a plurality of lifestyle factors. 4.The apparatus of claim 3, wherein the plurality of lifestyle factorsincludes meal size.
 5. The apparatus of claim 4, wherein the meal sizeis indicated with a subjective ranking.
 6. The apparatus of claim 3,wherein the plurality of lifestyle factors includes an energy level. 7.An apparatus for tracking blood glucose values and lifestyle factors,the apparatus including: a substrate having a front side including aplurality of regions for tracking blood glucose values, the plurality ofregions including a first region for recording an actual blood glucosevalue and a second region for placing a graphical marker indicating aselection of a first range of a plurality of ranges of blood glucosevalues, the plurality of ranges including at least one range below atarget range, at least one target range, and at least one range above atarget range.
 8. The apparatus of claim 7, wherein the substrate furtherincludes a second side including a portion having a plurality ofinstructions for using the plurality of regions for tracking bloodglucose values, the substrate being foldable such that the portionhaving the plurality of instructions on the second side overlap aportion of the front side.
 9. The apparatus of claim 8, wherein theplurality of instructions overlap a portion of the plurality of regionsfor tracking blood glucose values.
 10. The apparatus of claim 7, whereinthe front side further includes a plurality of regions for tracking aplurality of lifestyle factors.
 11. The apparatus of claim 10, whereinthe plurality of lifestyle factors includes meal size and a region fortracking the meal size is positioned above the first region.
 12. Theapparatus of claim 11, wherein the meal size is indicated with asubjective ranking.
 13. The apparatus of claim 10, wherein the pluralityof lifestyle factors includes an energy level and a region for trackingthe energy level is positioned above the first region.
 14. The apparatusof claim 7, wherein the target range is color-coded.
 15. A system fortracking physiological information with a blood glucose meter, thesystem including: a plurality of test strips for use with the bloodglucose meter; and a blood glucose and lifestyle factors trackingapparatus for recording a plurality of blood glucose values determinedby the blood glucose meter and at least one corresponding lifestylefactor associated with each one of the plurality of blood glucosereadings, wherein the plurality of test strips and the blood glucose andlifestyle factors tracking apparatus are provided as a kit.
 16. Thesystem of claim 15, wherein the blood glucose and lifestyle factorstracking apparatus is configured to receive multiple blood glucosevalues for consecutive days and to provide a graphical representation ofa glycemic control of the plurality of blood glucose values.
 17. Thesystem of claim 15, wherein the blood glucose and lifestyle factorstracking apparatus includes a first region for recording blood glucosevalues, a second region for recording indications of the at least onecorresponding lifestyle factor associated with each one of the pluralityof blood glucose readings, and a third region for graphing blood glucosevalues over time.
 18. The system of claim 17, wherein the second regionand the third region are visible together.
 19. The system of claim 17,wherein the third region includes a first visual indicator indicating atarget range for post-prandial blood glucose values and a second visualindicator indicating a target range for pre-prandial blood glucosevalues.
 20. The system of claim 15 , wherein the kit further includeseducational materials on meal planning.
 21. The system of claim 15,wherein the at least one corresponding lifestyle factor associated witheach one of the plurality of blood glucose readings a subjectiveindication of meal size.
 22. The system of claim 15, wherein the atleast one corresponding lifestyle factor associated with each one of theplurality of blood glucose readings includes an indication of energylevel.